FDA 510(k) Applications for Medical Device Product Code "DTP"
(Defoamer, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K912915 3M HEALTH CARE, LTD. SARNS NON-FILTERED VENOUS RESERVOIR 09/25/1991
K860702 3M HEALTH CARE, SARNS SARNS FILTERED CARDIOTOMY RESERVOIR 05/28/1986
K941654 3M HEALTH CARE, SARNS SARNS FILTERED VENOUS RESERVIOR MODIFICATION 07/26/1994
K872167 AMERICAN BENTLEY CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 09/01/1987
K842373 AMERICAN BENTLEY VENOUS RESERVOIR-BMR-1500-HARD SHELL 12/27/1984
K902856 C.R. BARD, INC. BARD FILTERED CARDIOTOMY RESERVOIR 09/27/1990
K962726 C.R. BARD, INC. BARD QUANTUM CVR 10/30/1996
K990514 C.R. BARD, INC. MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR 03/09/1999
K860775 CARDIO METRICS, INC. MEDIASTINAL AUTOTRANSFUSION SYSTEM 05/28/1986
K002591 COBE CARDIOVASCULAR, INC. COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR 09/13/2000
K004046 COBE CARDIOVASCULAR, INC. COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR 04/26/2001
K902437 COBE LABORATORIES, INC. COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER 12/17/1990
K984322 DIDECO S.P.A. DIDECO D920, LILLIPUT 1 TWIN RESERVOIR 03/02/1999
K844803 ELECTROMEDICS, INC. POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE 04/29/1985
K830727 ELECTROMICS, INC. CARDIOTOMY RESERVOIR-FILTERED & NON 04/05/1983
K874924 GISH BIOMEDICAL, INC. CAP-35 AND CAP35 F 01/19/1988
K851004 GISH BIOMEDICAL, INC. CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX 05/16/1985
K870792 GISH BIOMEDICAL, INC. THORASTAT ATR-XXXX 04/28/1987
K082412 MAPQUET CARDIOPULMONARY AG VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 11/10/2008
K101186 MEDTRONIC PERFUSION SYSTEMS AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG 09/03/2010
K933496 MEDTRONIC VASCULAR MAXIMA FILTERED HARDSHELL RESERVIOR 10/15/1993
K902355 MEDTRONIC VASCULAR MCR4000 & MCR4000F CARDIOTOMY RESERVOIR 08/23/1990
K911789 MEDTRONIC VASCULAR MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT 08/20/1991
K910568 MEDTRONIC VASCULAR MODEL 5866-46 SLEEVE KIT 04/09/1991
K834041 SCIMED LIFE SYSTEMS, INC. CARDIOTOMY RESERVOIR SC3500F 01/30/1984
K855049 SCIMED LIFE SYSTEMS, INC. MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR 02/26/1986
K820954 SCIMED LIFE SYSTEMS, INC. SCIMED MODEL SC 3000 05/24/1982
K840610 SCIMED LIFE SYSTEMS, INC. SCIMED MODEL SC4000 04/24/1984
K823731 SHILEY, INC. CARDF 01/05/1983
K832811 SHILEY, INC. SHILEY 3L CARDF PLUS 09/20/1983
K853503 SHILEY, INC. SHILEY 3L CARDIOTOMY RESERVOIR 11/14/1985
K801375 SHILEY, INC. SHILEY CARDIOTOMY RESERVOIR W/FILTER 07/14/1980
K821538 TERUMO MEDICAL CORP. CAPIOX CR-CARDIOTOMY RESERVOIR 08/06/1982
K801360 TRAVENOL LABORATORIES, S.A. CARDIOTOMY RESERVOIR WITH FILTER 07/14/1980


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact